FDA Device recall Z-0110-2016
Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitati…
- FDA Device
- Class II
- terminated
- Published 2015-10-14
On 2015-10-14 the FDA classified a Class II recall of Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitati… by Beckman Coulter, citing beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0110-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-31 |
| Published | 2015-10-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
Reason
Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.
Identifiers
| code_info | Lot: 431433 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0110-2016%22
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